Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206999
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2005-09-11
Brief Title:
The Effect of Imipramine on Early Information Processing
Sponsor:
Birte Glenthoj
Organization:
University of Copenhagen
Study Overview
Official Title:
Early Information Processing in Healthy Controls Studies on the Relation Between Two Different Paradigms PPI and P50ERP and Effects of Pharmacological Interventions
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We wanted to compare the relation of two different psychophysiological paradigms PrePulse Inhibition of the startle response PPI and P50 suppression to each other Additionally we wanted to test the effect of the combined serotonin- and noradrenaline re-uptake inhibitor imipramine on these measures The primary hypothesis was that PPI and P50 gating would not correlate with each other at baseline The secondary hypothesis was that increased noradrenergic and serotonergic activity would disrupt PPI as well as P50 gating
Detailed Description:
Schizophrenic patients exhibit impairments in filtering of sensory information as can be assessed by use of prepulse inhibition PPI of the acoustic startle response and P50 suppression paradigms In the treatment of negative symptoms or depressive syndromes during the course of schizophrenia antidepressants are often combined with antipsychotic medication However antidepressants increase monoaminergic activity of which in turn it has been suggested to decrease sensory gating although these presumptions are mostly based on results from animal studies Currently little is known about monoaminergic modulation of sensory filtering in humans and the few reports that can be found in literature show discrepancies with animal studies The current study was designed to study the effects of increased monoaminergic activity on sensory filtering and habituation of healthy volunteers In a double-blind placebo controlled cross-over design twenty healthy male volunteers will receive either placebo or a dose of 50 mg of imipramine a dual acting antidepressant after which they will be tested in a P50 suppression- a PPI- and a habituation of the startle reflex paradigm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KF 01-30599 | None | None | None |
| KF 11-06103 | None | None | None |
| KF 11-06803 | None | None | None |
| KF 11-09604 | None | None | None |